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Why data integrity is important to an API supplier

Why data integrity is important to an API supplier

By Lena Derjavets-Berezovsky, Sr Mgr TAPI Quality Assurance & Compliance

 

In our first article on DATA INTEGRITY we explained how TAPI implemented advanced computerized data management in our R&D departments. In this follow-up article we explain how and why TAPI manages it’s data in the manufacturing processes. Data that ensures our customers get the highest quality products each and every time.

Quality Affair Regulatory Affairs Article Guide How to

Regulatory requirements regarding DATA INTEGRITY has become increasingly demanding and increasingly a hot topic at every stage of drug production. TAPI is at the forefront of developing and implementing technology to comply with the present regulations and those to come in the future. To do this TAPI is committed to advanced technological solutions that will provide full control of data integrity in all processes of API manufacturing. Another goal is to have fully automated, paperless solutions that bring added value to our customers.

 

Why data integrity is so important

High level of data integrity is essential in the production of API’s as it guarantees the quality of the drug. It ensures that all the data related to drugs manufacture is preserved, and provides the information to prove the quality of the drug is 100% reliable and that all this data is easily accessible and available.

 

 

With high level of data integrity our customers can be assured that our products contain only those materials that are declared and nothing else. TAPI can provide guaranteed proof for this because of our high level of data integrity. And after all, when we are dealing with human lives we need to take the utmost care.

 

 

Control of this data is critical in drug production, as any imperfections in the process can directly affect the quality of the drug and cause harm to patients. To this end TAPI employs a range of computerized systems in every department along the manufacturing process from the very beginning of production until distribution.

 

Data Integrity In Production Environments

Data from the manufacturing process, analytical examination, and other support departments is kept accurate, attributable original and accessible. With our unique approach TAPI has the ability to make every system compliant, both new and old. In the following paragraphs we explain how we gather and manage our data throughout the production process so customers can be sure that the API’s we provide suit their needs and comply with local and global regulations.

Data Integrity is Integrated Throughout Our Support Departments

 

Engineering department is responsible for establishing our production systems and our data integrity assures our customers that these changes have been correctly managed. The department uses specialized software for P&ID management and the system is fully compliant with CFR Part 11 and Annex 11. Every change to the system is track-able and available.

 

 

Maintenance department, use software for instrument calibration that has user management, audit trail, time reference control, and backup function and assures the use of calibrated equipment for production of API.  This enables TAPI to assure our customers that we use calibrated equipment for API production.

 

 

Software for inventory of products and shipping management also complies fully with regulatory requirements. The software permits only released material to be used in production and enables tracking on expired materials etc. Our latest software innovation was to implement barcodes in the final packing of the material, where comparison of internal and external label by barcode assures 100% match and prevents any label errors. This way our customers can trust that they receive the correct material and documentation. TAPI has managed to reduce mistakes by 100%.

 

Streamlining our Laboratory compliance to enhance customer support

In our laboratory TAPI has around 25 different types of standalone software and the quality of the product is measured by these analytical systems. New upgrades are being constantly implemented to bring these systems to the highest level of compliance. This greatly helps us to support our customers with reliable data for their tests and ensures that our API’s are well within the required regulations.  These new features reduce paper work and give full control of the data exports from the analytical process.

 

 

Balances and titration systems that were managed manually have been dramatically upgraded by new technology. This greatly reduces the risk of errors and provides enhanced capabilities and faster testing times. All balances in TAPI are now connected to server-based software. This software collects the data from balances to the server. The software is fully compliant with the regulations and has user management, audit trail feature, backup functionality and time reference control. This means that users are managed by the software, date and time reference are managed by administration privileges and an audit trail is in place.

 

 

A virtual archive was created for retired standalone laboratory systems; it was a great solution making data accessible any time for a retention period of 10 years (according to regulation). The system was validated according to regulatory requirements. Data from old computerized systems is almost inaccessible with modern technology (for example WIN 2000 for Outlook), but our virtual archive provides the solution to these problems.

 

Getting your data has never been easier

Documentation management in TAPI is fully computerized, meaning that our customers can request data & documents via TAPI's online customers platform and download or be emailed the required data for their projects with us for free. Our systems are used for managing standard operating procedures, analytical methods, master batch cards, validation protocols and reports and more controlled documents. Master batch cards have control print that audits each printout of the document, with the reason for reprinting. The data is accessible and managed by version, with audit trail is in place. All the data backed up and protected. When our customers come to audit us, or when submitting documentation to the authorities prior to a product release, our data is readily available and complete.

 

Our customers know exactly what they are getting

TAPI successful management of data integrity means that our customers can guarantee and can be assured that their product is 100% exact every time. Each of our departments use different computerized systems, from the beginning of the API production through to the distribution of the material. Our experience and professionalism give us the ability to implement new technologies in very short time. All TAPI computerized systems enable high compliance with data integrity in all sites. Our deep knowledge of computerized software and regulatory requirements means that TAPI is constantly improving its capabilities in data integrity.

 

About the author

Lena Derjavets-Berezovsky is responsible for critical and computerized systems in the compliance department at TAPI. She has been at TEVA for the last 10 years, 5 years in the quality assurance department and 5 years in critical systems.

She has a B.Sc. in chemical engineering and a Master's degree in environmental engineering.

She is currently managing the critical and computerized systems team that is responsible for keeping all systems compliant with regulatory requirements.